BLISTEX LIP- dimethicone, camphor oil, menthol and phenol ointment 
HART Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BLISTEX LIP OINTMENT

Active Ingredients:

Dimethicone 1.1% (w/w)

Camphor 0.5% (w/w)

Menthol 0.6% (w/w)

Phenol 0.5% (w/w)

Purpose:

Skin protectant

External analgesic

External analgesic

External analgesic

Uses: for the temporary protection and relief of pain and itching associated with

Warnings: For external use only

Do not use

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Directions

Adults and children 2 years of age and over: apply liberally to affected area not more than 3 to 4 times daily

Children under 2 years of age: ask a doctor

Inactive Ingredients: Allontoin, Ammonium Hydroxide, Beeswax, Calcium Disodium EDTA, Calcium Hydroxide, Cetyl Alcohol, Flavors, Glycerin, Lanolin, Lauric Acid, Mineral Oil, Myristic Acid, Oleic Acid, Palmitic Acid, Paraffin, Petrolatum, Polyglyceryl-3 diisostearate, Potassium Hydroxide, Purified Water, SD Alcohol 36, Silica, Sodium Hydroxide, Sodium Saccharin, Stearyl Alcohol

Blistex.jpg

Blistex.jpg

BLISTEX LIP 
dimethicone, camphor, menthol, phenol ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0029
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1.1 g  in 100 g
CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727) CAMPHOR OIL .5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL .6 g  in 100 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL .5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN (UNII: 344S277G0Z)  
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
LAURIC ACID (UNII: 1160N9NU9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
MYRISTIC ACID (UNII: 0I3V7S25AW)  
OLEIC ACID (UNII: 2UMI9U37CP)  
PALMITIC ACID (UNII: 2V16EO95H1)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50332-0029-2 25 in 1 BOX, UNIT-DOSE
1 .5 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 08/09/1995
Labeler - HART Health (069560969)

Revised: 11/2012
Document Id: ef848a1c-6ea9-44d9-a5da-e0554a133ee0
Set id: 63300820-80ca-432f-b86d-ef15d878671b
Version: 1
Effective Time: 20121113
 
HART Health